NCBIO members were briefed in March on work at the national
level to renew and expand user fee programs supporting FDA review of new
pharmaceutical and medical device products.
Andrew Emmett, Managing Director for Science and Regulatory Affairs for
the Biotechnology Industry Organization, told NCBIO Emerging Company Forum
attendees on March 14 that improvements to the Prescription Drug User Fee Act
will increase transparency and scientific communication at key points during
FDA's review of new drugs. On March
28, J.C. Scott, Senior Executive Vice President for Government Affairs at
AdavMed, told NCBIO's Medical Device Forum that changes to the Medical Device
User Fee Act will establish new total review time metrics for FDA's medical
device review process. NCBIO is
working with BIO and AdvaMed in support of timely enactment of the new user fee
arrangements. Current user fee
legislation expires September 30,2012.